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FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

SMG 1410.411 - ORDERS TO REPAIR OR REPLACE, OR MAKE REFUNDS FOR, MEDICAL DEVICES

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The following officials, for medical devices assigned to their respective organizations, are authorized to order repair or replacement of, or refund for, medical devices under section 518(b) and (c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(b) and (c)):

1. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH), the Director and Deputy Director, Office of Compliance, CDRH, and the Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety, CDRH.

2. The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER.

3. The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); and the Director and Deputy Director, Office of Compliance, CDER.

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

This delegation was approved on April 14, 2003.

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